PROFILE (2819-MA-1003)
Research type
Research Study
Full title
Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium Difficile Infection (CDI)
IRAS ID
167924
Contact name
Nico Hanssen
Contact email
Sponsor organisation
Astellas Pharma Europe Ltd.
Eudract number
2014-003002-32
Duration of Study in the UK
1 years, 7 months, 28 days
Research summary
Clostridium Difficile Infection (CDI) is caused by an overgrowth of bacteria called C. difficile in the colon which can cause severe diarrhoea. The condition is mostly seen in hospitalized patients that have received previous antibiotic treatments.
An important problem after having an initial episode of CDI is recurrence. This is when the disease returns after treatment has stopped. This has been proved less frequent in patients treated with fidaxomicin.
The main purpose of the study is to find out if blood levels of fidaxomicin and its main metabolite (an active chemical which remains after fidaxomicin has been broken down by the body) are higher in subjects with Inflammatory Bowel Disease (IBD) compared to the non-IBD population and if it is safe to use in this population.
Participation in the study will last approximately 6 months. There will be 8 visit with research staff. All subjects enrolled will receive the same treatment - fidaxomicin 200 mg tablets, taken twice daily, for 10 days. During the treatment period, subjects will be asked to complete a diary and enter information daily about every bowel movement, other symptoms they might experience and the times at which the study drug was taken each day.
At Day 1 (Visit 1), Day 5 (Visit 2) and Day 10 (Visit 3) subjects will be asked to provide a series of blood samples to measure the concentration of fidaxomicin and its main metabolite. These are called pharmacokinetic (PK) samples. On these days blood samples will be taken just prior to taking the morning dose of study drug and then at 30 minutes and 1, 1.5, 2, 3, 4, 5 and 12 hours after dosing. Subjects will then be followed up at scheduled time points (study Day 26, 40, 90 and 180) to check that they no longer have CDI and to monitor thier overall health.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0133
Date of REC Opinion
30 Mar 2015
REC opinion
Unfavourable Opinion